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Scrutiny on health care professional transparency and inducement in the Netherlands

On 8 April 2024, the Dutch Minister of Medical Care sent a letter to Dutch Parliament (in Dutch: “Tweede Kamer”) regarding interactions between life sciences companies and...

Insights and Analysis

Life Science Law Update – Key developments for pharma & device companies in EU

The Q1/24 Life Science and Health Care Law Update covers key trends across EU life sciences regulatory, corporate, compliance, competition, and privacy.Key new developments: Pharma: EC ...

News

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate...

News

Repairing the supply chain

Now it’s adopted by the EU Parliament: the EU Directive on a right to repair. This proposal is a game changer. It affects manufacturers and sellers alike, and provides new ...

News

UK MHRA Publishes AI Regulatory Strategy

On 30 April 2024, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published its strategic approach to AI and the steps it is taking to implement the UK Government's AI ...

News

HRSA issues 340B Program final rule modifying administrative dispute resolution process

On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative ...

News

2024 Life Sciences & Health Care Horizons

While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent ...

News

The False Claims Act Guide: 2023 and the road ahead

In the latest edition of our False Claims Act Guide: 2023 and the road ahead, we analyze the key developments from 2023 and discuss how the most important cases and issues are shaping FCA...

News

U.S. device makers get 2 years to comply with FDA Quality Management System Regulations final rule

The U.S. Food and Drug Administration (FDA) published its long-awaited final rule to amend the Quality System Regulation’s (QSR’s) current good manufacturing practice (CGMP)...

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